MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN PI CVC KIT: 2-L 8 FR X 6" (1; CATHETER,INTRAVASCULAR,THERAP

Catalog Number ASK-42802-AKP1A

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: anesthesiologist said the tip of the dilator met no resistance upon insertion but when he went to remove it, it seemed to have been frayed or damaged.He is unsure how this happened, if it was from the wire or insertion.No patient injury or complication reported.The patient's condition is reported as fine.

Event Description

The complaint is reported as: anesthesiologist said the tip of the dilator met no resistance upon insertion but when he went to remove it, it seemed to have been frayed or damaged.He is unsure how this happened, if it was from the wire or insertion.No patient injury or complication reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing the damage to the dilator tip.A probable cause of the dilator tip damage cannot be determined from the photo and without the sample to evaluate.A device history record review was performed with no evidence to suggest a manufacturing related cause.The ifu provided with this kit informs the user: "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." "do not leave tissue dilator in place as an indwelling catheter.Leaving tissue dilator in place puts patient at risk for possible vessel wall perforation." the report that the dilator tip was damaged was confirmed through examination of the customer supplied photo.The image showed the dilator tip was damaged; however, the actual complaint sample was not returned for evaluation.The device history record was reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the dilator tip damage could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 2-L 8 FR X 6" (1
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10867627
• MDR Text Key: 217095065
• Report Number: 9680794-2020-00465
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: ASK-42802-AKP1A
• Device Lot Number: 13F20G0588
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.